Members of the FDA’s Antimicrobial Drugs Advisory Committee were split in their vote to recommend molnupiravir, which can reduce the risk someone will progress to severe disease or death by about 30%.
If authorization is granted, the drug would be the first oral antiviral treatment to fight Covid-19. It comes in capsule form.
The pills must be taken within five days of the start of symptoms to do much good, and people must take pills twice a day for five days. Members of the committee were worried about risks to pregnant women.
The FDA will soon decide on Merck's Covid-19 antiviral pill. It shows promise, but there are also concerns
Molnupiravir is not the only antiviral scientists are developing against Covid-19. Pfizer applied for authorization of its antiviral pill this month. The FDA has not yet set a date for its advisory panel to review that drug.
The FDA will now consider the committee’s recommendation. It doesn’t have to follow the committee’s advice, but often does.
The US federal government has contracted to buy 3.1 million courses of molnupiravir for $2.2 billion, which works out to about $700 per course of treatment.

It’s too soon to know if the Omicron variant of coronavirus causes less severe disease than the Delta variant – in spite of reports that many cases so far have been mild, Dr. Anthony Fauci said Tuesday.

Most cases of Covid-19 overall are mild, and especially among younger patients. But nonetheless the virus can and does cause severe disease as it spreads among populations and has killed 5.2 million people globally and more than 779,000 in the US alone, according to Johns Hopkins University.

Fauci, who is director of the National Institute of Allergy and Infectious Diseases, noted that some South African physicians have reported the patients they treated had mild disease. But they were treating young people, Fauci said.

“We believe that it is too soon to tell of what the level of severity is,” Fauci told a White House Covid-19 briefing.

“Dr. Walensky and I specifically asked our South African colleagues that on the most recent Zoom call that we had, and they agreed with us that it’s too early to tell. They’re hoping that it is going to, across the board, give a lower level of severity, but they don’t know that right now,” he added.

In the meantime, vaccination and boosters should protect people, Fauci said. Boosters, especially, can bring antibody levels up to where there is a cushion of extra protection that can cover even variants of the virus.

“And that’s usually most manifested in protection against severe disease that leads to hospitalization,” Fauci said.

“So when we say that although these mutations suggest a diminution of protection and a degree of immune evasion, still from the experience that we have with Delta (you) can make a reasonable conclusion that you would not eliminate all protection against this particular variant,” he said.

“And that’s the reason why we don’t know what that degree of diminution of protection is going to be. But we know that when you boost somebody, you elevate your level of protection very high. And we are hoping, and I think with good reason, to feel good that there will be some degree of protection. Therefore, as we said, if you’re unvaccinated get vaccinated, and if you’re vaccinated, get boosted,” he added.

In a memo to the Joint Chiefs chairman, the service secretaries and the head of the National Guard Bureau, Austin wrote that Pentagon funds cannot be used “for payment of duties performed under Title 32 for members of the National Guard who do not comply” with the military’s vaccine requirement.
Title 32 refers to National Guard operations under state orders, as opposed to operations under federal orders, which are called Title 10. Both are paid for by the federal government.
Austin’s memo comes a day after he rejected a request for an exemption to the vaccine mandate from Oklahoma Gov. Kevin Stitt. In a letter written earlier this month, the Republican governor had argued that the requirement “violates the personal freedoms of many Oklahomans” and could cause them to “potentially sacrifice their personal beliefs.” Stitt also argued that Oklahoma would need all of its National Guard members for the upcoming winter and the possibility of winter storms.
Pentagon denies Oklahoma governor's request and insists National Guard members must be vaccinated
But Austin dismissed these arguments. “The concerns raised in your letter do not negate the need for this important military readiness requirement,” he wrote in a letter to Stitt on Monday.
Nevertheless, Stitt did not appear ready to back down. He insisted that he remains the commander in chief of the Oklahoma National Guard as long as it operates under Title 32 orders.
Stitt had instructed his recently appointed commander of the Oklahoma National Guard, Brig. Gen. Thomas Mancino, not to enforce the mandate. Mancino, who acknowledged it put him in an awkward situation, said that under state orders, his commander was the governor. But he also said that if the guard were called up under federal orders, he would enforce the vaccine requirement.
On Tuesday, Austin made clear the consequences of a failure to comply with the military’s vaccine mandate, regardless of whether the guard unit was operating under state or federal orders.
In the memo, first reported by NBC News, Austin said members of the National Guard must become vaccinated “in order to participate in drills, training and other duty conducted under title 32.”
“No credit or excused absence shall be afforded to members who do not participate in drills, training, or other duty due to failure to be fully vaccinated against COVID-19,” he wrote.
Austin also said the vaccination requirement applies to the Ready Reserve, a component of the military’s reserve forces that must be prepared for mobilization within a specified period of time.
On Monday, Pentagon press secretary John Kirby reiterated that guard members’ failure to get vaccinated risks their participation in the National Guard.
“One could elect not to take the vaccine, of course, but then you would be putting at jeopardy your ability to stay in the National Guard,” Kirby said at a news briefing.
“The question presented here is narrow. Can the president use congressionally delegated authority to manage the federal procurement of goods and services to impose vaccines on the employees of federal contractors and subcontractors?” US District Judge Gregory Frederick Van Tatenhove, a President George W. Bush appointee, in Kentucky said in the 29-page opinion. “In all likelihood, the answer to that question is no.”
The judge said the President had exceeded his authority under the Federal Property and Administrative Services Act in issuing the requirement. “While the statute grants to the president great discretion, it strains credulity that Congress intended the FPASA, a procurement statute, to be the basis for promulgating a public health measure such as mandatory vaccination,” the judge said.
He also said he was “concerned that the vaccine mandate intrudes on an area that is traditionally reserved to the States.”
The judge’s opinion stressed that the case was not about whether vaccines are effective or whether the government can require them in certain circumstances. It included only a limited discussion of why the public interest in halting the mandate outweighed keeping it in force while it was more fully litigated.
“Plaintiff agencies and contractors are now having to make tough choices about whether they will choose to comply with the vaccine mandate or lose out on future federal government contracts,” the judge said.
Ohio Attorney General Dave Yost, who joined his counterparts in Kentucky and Tennessee in bringing the case, said in a statement after the order came down that “this is not about vaccines, it’s about the mandates.”
“The judge’s opinion clearly states that and it has been our position all along that the president cannot impose these mandates on the people,” Yost said.
While the contractor requirement was blocked in only three states, it is the latest instance of the administration’s mandate meeting resistance in court. In recent weeks, an appeals court froze a mandate that required large companies’ employees to be vaccinated or submit to regular questioning over their status. That order is now under review by a separate appeals court.
On Monday, a judge in Missouri halted a Biden vaccine requirement for certain health care workers in 10 states. The Justice Department is appealing that case to an appeals court.

It’s too soon to know if the Omicron variant of coronavirus causes less severe disease than the Delta variant – in spite of reports that many cases so far have been mild, Dr. Anthony Fauci said Tuesday.

Most cases of Covid-19 overall are mild, and especially among younger patients. But nonetheless the virus can and does cause severe disease as it spreads among populations and has killed 5.2 million people globally and more than 779,000 in the US alone, according to Johns Hopkins University.

Fauci, who is director of the National Institute of Allergy and Infectious Diseases, noted that some South African physicians have reported the patients they treated had mild disease. But they were treating young people, Fauci said.

“We believe that it is too soon to tell of what the level of severity is,” Fauci told a White House Covid-19 briefing.

“Dr. Walensky and I specifically asked our South African colleagues that on the most recent Zoom call that we had, and they agreed with us that it’s too early to tell. They’re hoping that it is going to, across the board, give a lower level of severity, but they don’t know that right now,” he added.

In the meantime, vaccination and boosters should protect people, Fauci said. Boosters, especially, can bring antibody levels up to where there is a cushion of extra protection that can cover even variants of the virus.

“And that’s usually most manifested in protection against severe disease that leads to hospitalization,” Fauci said.

“So when we say that although these mutations suggest a diminution of protection and a degree of immune evasion, still from the experience that we have with Delta (you) can make a reasonable conclusion that you would not eliminate all protection against this particular variant,” he said.

“And that’s the reason why we don’t know what that degree of diminution of protection is going to be. But we know that when you boost somebody, you elevate your level of protection very high. And we are hoping, and I think with good reason, to feel good that there will be some degree of protection. Therefore, as we said, if you’re unvaccinated get vaccinated, and if you’re vaccinated, get boosted,” he added.

The company’s reporting amounts to a “hidden pandemic,” according to a coalition of four unions interested in establishing representation for Amazon workers.
“The company systematically failed to record Covid-19 cases in its warehouses, recording only 27 work-related illnesses for all of 2020 in the category that includes Covid-19 infections,” said the report from the Strategic Organizing Center, which is made up of the Teamsters union, the Service Employees Union, the Communication Workers of America and the United Farm Workers of America.
The group notes that Amazon put out a statement to employees on October 1, 2020, in which it said that 19,816 US employees had tested positive for Covid through September 19 of that year, prior to the late-year surge that increased the number of cases nationwide.
The labor group has sent a complaint to Assistant Secretary of Labor Douglas Parker, urging the Occupational Health and Safety Administration to investigate Amazon’s “disturbing pattern of misleading or grossly incomplete information provided to authorities around Covid-19 cases in its warehouses.”
“Amazon, the nation’s second largest private employer, put workers’ lives at risk by depriving OSHA of information about Covid-19 cases in its facilities, undermining the agency’s ability to identify workplace hazards and to hold the company accountable for unsafe conditions,” the group said.
Amazon did not challenge the number of cases cited by the group, but called its report an intentionally misleading effort to paint a false picture of the statistics that Amazon filed with OSHA.
“OSHA has acknowledged that assessing whether a Covid case was caused through exposure in the workplace vs. in the community is difficult,” said Amazon’s statement. “OSHA has provided employers with guidance about when to record cases as workplace related exposure and we have worked to follow this guidance throughout the pandemic. Additionally, we also communicate regularly with our employees and local health authorities.
“While we know we aren’t perfect, we’re working hard every day to listen to the experts and keep our teams and communities safe, which has included incurring more than $15 billion in costs for things like extensive contact tracing, on-site vaccine clinics and testing, and hundreds of process changes and health measures,” said the company.
The report that Amazon provided to employees in October last year said that the 19,816 positive tests were among the 1.4 million front-line US employees of Amazon and Whole Foods.
The company’s report also stated that an analysis comparing its employee infection rate to the infection rate among the general population showed that the Amazon infection rate was 42% lower than what would have been found in the overall US population during the same period. Amazon said it controlled for both age and geographic distribution of workers when doing the analysis.
But the main point that Amazon made in the October notice to employees is that it couldn’t say where those who tested positive had become infected.
“A positive test does not mean someone became infected as a result of their employment with Amazon — these individuals can be exposed in many ways outside of work,” the company said.
Amazon has faced complaints from both employees and some public officials that it is not doing enough to protect workers from the transmission of Covid while on the job. New York Attorney General Letitia James filed suit earlier this year charging that “throughout the historic pandemic, Amazon has repeatedly and persistently failed to comply with its obligation to institute reasonable and adequate measures to protect its workers from the spread of the virus.”
Specifically the AG charges that Amazon has failed to comply with requirements for cleaning and disinfecting workplaces where infected workers had been, as well as not notifying potential contacts of infected workers. James also said Amazon’s demands for productivity from its workers did not allow them sufficient time to “engage in hygiene, sanitation, social-distancing, and necessary cleaning practices.”
Amazon has denied it is not doing what is necessary to protect its workers, but the company has lost efforts to block James from pursuing the case in court.
Amazon warehouse workers in Alabama will get another chance to unionize
Amazon, as the nation’s second largest private sector employer, and one of its fastest growing, has become a top target of unions hoping to win the right to represent workers at various facilities.
The union coalition making the complaint to OSHA Tuesday does not include the Retail, Wholesale and Department Store Union, which is looking to represent the workers at an Amazon warehouse in Bessemer, Alabama. That union, which lost an initial organizing vote at that Amazon facility in April, had a National Labor Relations Board regional director order a new vote Monday due to findings of misconduct by Amazon during the earlier vote. Amazon said it will fight that organizing effort once again.
The coalition also doesn’t include an independent union seeking to organize workers at the Staten Island, New York, facility cited in James’ complaint.
The case is before the US Court of Appeals for the DC Circuit, after a federal judge earlier this month declined to halt the release of the Trump documents from the National Archives. President Joe Biden is declining to assert executive privilege on the documents, so Trump is asking the court to consider his assertion of privilege instead.
The case touches on some unsettled law around whether a former president can litigate executive privilege claims when the incumbent sides with transparency. And the three judges on the appellate panel — all Democratic appointees — signaled that they found some of the case’s questions difficult, even as they expressed doubt about Trump’s claims.
It’s nearly guaranteed that, however they rule, the case will end up appealed to the Supreme Court.
Here’s what to know from the hearing:

Judges ask why a former president should get to overrule the current one

The appeals court showed little sympathy for Trump’s arguments for blocking the documents’ release.
“Why should the former president be the one to make that determination when you’re talking about accommodating another branch of government?” Judge Ketanji Brown Jackson said while the Trump team was arguing its case.
“It would seem that the current president has not only the confidentiality factor that he’s thinking about, but the current duty to the interests of the United States even broader than those that the former president would be concerned about,” she added.
Judge Patricia Millett grilled Trump lawyer Justin Clark on what else the court is supposed to weigh in considering these kinds of disputes.
“You’re going to have to come up with something with more power to outweigh the incumbent president’s decision to waive,” Millett said. “You’re going to have to change the score on that scoreboard,” which, the judge said, would already be stacked with points in the president’s favor according to Supreme Court precedent.

The court appeared very uninterested in reviewing the White House records document by document.

In a series of troubling signs for Trump, the judges pushed back strongly on a request from the former President’s legal team that the court review records from his presidency, document by document, to determine whether they should be withheld from Congress.
Trump’s approach would have likely dragged out court proceedings — effectively blocking the House from access for an extended time. The trial-level judge previously rejected this suggestion.
“The issue, as I understood, before us was not about the content of the documents or when you look at them, but simply what happens when the current incumbent president says I’m not going to invoke executive privilege as to these documents with respect to this particular request,” Millett said early in Tuesday’s hearing.
Judge Robert Wilkins said Trump’s arguments for a document-by-document review were “inconsistent” with Nixon-era court precedent.
“That’s not the way we say we do this, at least the way I read those cases,” Wilkins said. He pointed out that the court considering Nixon’s case didn’t listen to the Watergate tapes one by one.

There are big questions this court may need to address if a former president and current president disagree

As rocky as the hearing went for the Trump side, the panel’s judges signaled that they were struggling with what a court could ultimately do to settle a standoff between former and current presidents.
“We don’t just flip a coin or draw straws or something. What, what tests are we supposed to use?” Wilkins asked Doug Letter, the lawyer representing the House January 6 committee.
The judges pointed out that the law governing historical records going to Congress doesn’t spell out what should happen if a former president keeps pushing a challenge against the current president on a privilege decision.
They also challenged the lawyers with several hypothetical scenarios — a current president releasing documents to “avenge” his predecessor, a former president claiming a release of his White House documents would endanger the lives of US agents abroad, or four former presidents imploring a current president to keep sensitive information private — to grill Trump’s opponents on whether there was any situation in which an incumbent’s privilege determination could be second-guessed by a court.
The judges also asked whether the court could stop Congress from publicly releasing White House documents it obtained from the National Archives. In this case, Congress couldn’t guarantee absolute secrecy, Letter, the House lawyer, pointed out.
Letter brushed off the hypothetical scenarios, describing them as far afield from the case before the court. He stressed that in this dispute there was no clash between the legislative and executive branches, so there was no separation-of-powers question that the court needed to resolve.
Brian Boynton, a lawyer for the Justice Department, took a different approach to helping the court navigate those questions. He suggested that it avoid making any sweeping conclusion about whether courts can ever side with a former president in privilege disputes with incumbents.
“We don’t think you need to or should issue a ruling that says the incumbent always wins, because this is an unsettled area of the law and there’s no need to reach that conclusion here,” Boynton said.
Still, Boynton maintained that few scenarios exist where a former president could override the decisions of the current office-holder.

A request that the Supreme Court get involved could be coming very soon

Since Trump brought the lawsuit last month, he’s had to act quickly in seeking court orders that would stop the documents’ disclosure, as the National Archives had originally planned to release the first tranche of the hundreds of pages in question on November 12.
US District Judge Tanya Chutkan, who oversaw the first round of the litigation, ruled against Trump before that deadline, but the appeals court put an administrative hold on the documents’ release and so far has moved very quickly to advance the case.
The pause was already affecting the House’s investigation, with subpoenaed witnesses such as Steve Bannon and former Trump White House chief of staff Mark Meadows pointing to the ongoing court case to either avoid or delay cooperating with the House.
As Tuesday’s hearing was wrapping up, Millett acknowledged that the case was “very, very urgent and everyone needs to proceed on a very tight timeline.” She suggested that if the court were to rule against Trump, it could still put in place a two-week hold preventing he National Archives from releasing the documents, so the case could be appealed to the Supreme Court.
“I was informed after the tour, I learned about a school shooting in Michigan. As we learn the full details my heart goes out to the families enduring the unimaginable grief of losing a loved one,” Biden said at the start of a speech in Minnesota.
Biden said the suspect “turned himself in and claimed his right against self-incrimination and turned over his pistol. That’s all that we know about it.”
Three people have died and six more were injured in the shooting Tuesday afternoon at Oxford High School in Oxford, Michigan, authorities said. The three killed are believed to be students, Oakland County Undersheriff Michael G. McCabe said at a news conference, and one of those shot is believed to be a teacher. The suspect was identified as a 15-year-old sophomore boy and is in custody, McCabe said.
“You gotta know that whole community has to be just in a state of shock right now,” Biden added.
This is a breaking story and will be updated.
Moshe Porat, 74, was the dean of Temple University’s Fox School of Business and Management from 1996 to 2018. His federal trial began November 10, and jurors returned the guilty verdicts on Monday.
According to an April 2021 indictment, Porat conspired with Isaac Gottlieb, a statistics professor at Fox, and Marjorie O’Neill, manager of finance at Fox, to give false information to US News about Fox’s online MBA (OMBA) and part-time MBA (PMBA) programs. In particular, they falsely stated how many students took the GMAT, their average work experience and the percentage of students who were enrolled part time, the indictment states.
Gottlieb and O’Neill have both pleaded guilty to conspiracy and have not yet been sentenced, according to court records.
“Today, a jury reaffirmed that wire fraud is a federal crime even when perpetrated within the system of higher education in the United States,” US Attorney Jennifer Arbittier Williams said in a statement Monday. “Moshe Porat misrepresented information about Fox’s application and acceptance process, and therefore about the student-body itself, in order to defraud the rankings system, potential students, and donors.
“This case was certainly unusual, but at its foundation it is just a case of fraud and underlying greed,” she added.
Cheat. Bribe. Lie. Here's how the college admissions scam allegedly worked
Attorneys for Porat did not respond to a request for comment.
The trial comes just a couple years after prosecutors arrested dozens of parents, college coaches and administrators in the sprawling college admissions scam known as “Operation Varsity Blues.”
In addition, the case highlights the enduring power of the US News and World Report college rankings, which attempt to turn the complex experience of higher education into hard and fast rankings. Over the years, these rankings have taken on a major role in how people decide where to apply, and the schools themselves have adjusted accordingly.
The Best Colleges rankings have long been criticized by higher education experts. Stephen Joel Trachtenberg, former president of George Washington University, has called them a “racket” and said schools feel pressure to game the rankings.
“Just as athletes use steroids and gambling happens at Rick’s, colleges and universities succumb to their own set of pressures, including the desire to be on top in the rankings,” he wrote in a 2012 opinion piece for CNN.
In 2019, for example, the US News & World Report said the University of Oklahoma gave “inflated” data on its alumni giving rates for two decades, boosting its placement in several of their rankings. The university said it discovered the “misreporting of donations” in 2018 and provided the updated information to US News immediately afterward.

How the scheme worked

The scheme devised by Porat, Gottlieb and O’Neill was, for a time, remarkably successful.
Using the juiced numbers, US News ranked Fox’s OMBA program as the best in the country from 2015 to 2018, and Fox’s PMBA program rose in the US News rankings from 53rd in 2014 up to 7th in 2017. Porat used these rankings in the school’s marketing materials, and enrollment in the programs increased significantly, the indictment states.
And then it all came crashing down. On January 8, 2018, the website Poets & Quants published an article about the MBA rankings that noted suspiciously that Fox claimed all of its OMBA students had taken the GMAT. Fox administrators and officials saw the article and, in a meeting with Porat and others, became concerned because they knew that data was inaccurate, the indictment states.
University of Oklahoma gave false data to U.S. News college rankings for 20 yearsUniversity of Oklahoma gave false data to U.S. News college rankings for 20 years
Despite that meeting, Porat gave a champagne toast touting the school’s latest No. 1 ranking, and a few hours later sent out a marketing email boasting of the latest top ranking, the indictment states.
Two weeks later, US News announced it would remove Fox Business School from its OMBA rankings due to the data issue. Temple hired the outside law firm Jones Day to investigate the incident, and Porat, Gottlieb and O’Neill gave “false or misleading” statements to the investigators, the indictment states.
The Jones Day review found that Fox had misreported data for its OMBA program since at least 2014, sometimes intentionally, and had similar misreporting in a number of other graduate programs. In 2019, Temple and the Pennsylvania Office of Attorney General agreed to a settlement creating $250,000 in new scholarships for students.
On its website, Temple University has set up a dedicated FAQ section explaining the scandal and how the school has responded. University spokesman Stephen Orbanek also issued a statement on the guilty verdict.
“We respect the justice system and the jury’s decision in this matter. The evidence presented at the trial speaks for itself but is not representative of Temple or the overwhelming majority of the thousands of educational professionals serving our students,” Orbanek said. “This is an unhappy moment for our students and alumni, but our focus remains on delivering the best possible outcomes for our students.”